Validant understands that Biotechnology, Pharmaceutical and Medical Device companies face a complex and ever-changing regulatory landscape. In today’s climate the management of risk and compliance with regulations is a constant. Peaks in workload or unforeseen events can create the need for more resources, quickly. We offer clients a unique portfolio of expertise – from individual subject matter experts to comprehensive, cross-functional project-based solutions – that is flexible, rapidly deployable, scalable and appropriate:

 

Validant Services
  • Laboratory Services
  • Technical / Product Transfer
  • Engineering Services
  • Design Services
  • Packaging and Labeling
  • Supplier Audits
  • Supplier Qualification
  • Affiliate Audits
  • Third Party Logistics
  • Equipment and Instrument Qualification (IOPQ)
  • Production and Process Controls – Batch Record
  • Product, Process and Cleaning Validation
  • Methods Validation; CSV (Computer System Validation)
  • Equipment and Facility Design, Construction and Commissioning
  • Facilities Management
  • Stability Program Assessment
  • Design Control
  • Quality Engineering
  • Quality Audits
  • Systems Integration
  • Quality and CAPA Training
  • Quality Systems Certification
  • Complaint Response
  • Product Recalls
  • Response Development and Implementation Plans for Regulatory Compliance
  • Pre-Product Assessment
  • Remediation Planning
  • Regulatory Insights / Consulting
  • Process Improvement
  • Organizational Assessments
  • Planning, Forecasting and Resource Requirements
Validant Services